75 mg, 600 mg film-coated tablets
darunavir
What is Darunavir Sandoz?
Darunavir Sandoz contains the active substance darunavir. Darunavir Sandoz is an antiretroviral medicine used to treat human immunodeficiency virus ( HIV ) infection. It belongs to a group of medicines called protease inhibitors. Darunavir Sandoz works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses associated with HIV – infection.
What is it used for?
Darunavir Sandoz is used to treating adults and children over 3 years of age who weigh at least 15 kg who are infected with HIV and who have already used other antiretroviral medicines.
Darunavir Sandoz must be taken in combination with a low dose of ritonavir and other HIV medicines. Your doctor will discuss with you which drug combination is best for you.
Darunavir contained in Darunavir Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
- if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
- if you have severe liver disease. Talk to your doctor if you are unsure about the severity of your liver disease. Additional tests may be necessary.
Do not combine Darunavir Sandoz with any of the following medicines
If you take any of these, ask your doctor if you can switch to another medicine.
| Drug | Area of the use of the drug |
| Avanafil | to treat erection problems |
| Astemizole or terfenadine | to treat allergy symptoms |
| Triazolam and midazolam took by mouth | to help you sleep and/or to relieve anxiety |
| Cisapride | to treat certain stomach problems |
| Colchicine (if you have kidney and/or liver problems) | to treat gout or familial Mediterranean fever |
| Lurasidone, pimozide, quetiapine, or sertindole | to treat psychiatric conditions |
| Ergotamine alkaloids such as ergotamine, dihydroergotamine, ergonovine andmethylergometrine (methylergonovine) | to treat migraine headaches |
| Amiodarone, bepridil, dronedarone, quinidine, ranolazine | to treat certain heart diseases, e.g.irregular heartbeat |
| Lovastatin, simvastatin, and lomitapide | to lower cholesterol levels |
| Rifampicin | to treat the certain infection you such as tuberculosis |
| The combination drug lopinavir/ritonavir | this anti- HIV drug belongs to the same class as darunavir Sandoz |
| Elbasvir / grazoprevir | to treat hepatitis C infection |
| Alfuzosin | for the treatment of enlarged prostate |
| Sildenafil | for the treatment of high blood pressure in the blood vessels in the lungs |
| Dabigatran, ticagrelor | to prevent platelets from clotting the treatment of patients who have had one myocardial infarction |
Do not take Darunavir Sandoz with (traditional) herbal medicines containing St. John’s wort (Hypericum perforatum).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Darunavir Sandoz.
Sandoz Darunavir does not cure HIV – infection. You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.
People taking Darunavir Sandoz may still develop infections you or other illnesses associated with HIV – infection. You must continue to have regular contact with your doctor.
People taking Darunavir Sandoz may develop skin rashes. In rare cases, a rash can be serious or potentially life-threatening. Always consult your doctor if you develop a rash.
Rashes (generally mild or moderate) may occur more frequently in patients taking both Sandoz and Darunavir raltegravir (at HIV – infection ) than in patients taking either of these drugs.
Inform your doctor about your situation BEFORE and DURING your treatment
Check the following points and tell your doctor if any of these apply to you.
- Tell your doctor if you have a history of liver problems, including hepatitis B or C infection. Your doctor may assess the severity of your liver disease before deciding if you can take Darunavir Sandoz.
- Tell your doctor if you have diabetes. Darunavir Sandoz may increase blood sugar levels.
- Tell your doctor immediately if you notice any symptoms of infection (such as enlarged lymph nodes or fever). In some patients with advanced HIV – infection and a history of opportunistic infection, signs, and symptoms of inflammation from previous infections may occur soon after treatment with HIV -läkemedel began. It is believed that these symptoms are due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present without giving clear symptoms.
- In addition to opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.
- Tell your doctor if you have hemophilia. Darunavir Sandoz may increase the risk of bleeding.
- Tell your doctor if you are allergic to sulphonamides (such as those used to treat certain infections ).
- Tell your doctor if you notice problems with muscles and bones. Some patients taking combination antiviral therapy may develop a skeletal disease called osteonecrosis (dead bone tissue due to loss of blood supply to the skeleton). The duration of combination antiviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (severely weakened immune system), and high BMI ( body mass index ) can be some of the many risk factors for developing the disease. Signs of osteonecrosis are stiff and aching joints (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, talk to your doctor.
Older
Darunavir Sandoz has only been used in a limited number of patients aged 65 years or older. If you belong to this age group, discuss with your doctor if you can use Darunavir Sandoz.
Children
Darunavir Sandoz should not be used in children under 3 years of age or weighing less than 15 kg.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are certain medicines that you must not combine with Darunavir Sandoz. These are listed above under the heading “Do not combine Darunavir Sandoz with any of the following medicines”.
In most cases, Darunavir Sandoz can be combined with other classes of anti- HIV medicines (eg NRTIs ( nucleoside analogs), NNRTInon-nucleosideide analogs), CCR5 antagonists, and FIs (fusion inhibitors). Darunavir Sandoz together with ritonavir has not been tested with all PIs ( protease inhibitors ) and must not be used with other HIV -PI preparations. In some cases, the dosage of the other drugs may have to be changed. therefore, always tell your doctor if you are taking other medicines for HIV and carefully follow your doctor’s instructions on which medicines can be combined.
The effect of Darunavir Sandoz may be reduced if you take any of the following medicines.
Tell your doctor if you are taking:
- phenobarbital, phenytoin (to prevent seizures)
- dexamethasone ( corticosteroid )
- efavirenz (against HIV – infection )
- boceprevir (for hepatitis C infection )
- rifapentine, rifabutin (medicines to treat certain infections, such as tuberculosis )
- saquinavir (against HIV – infection ).
The effects of other medicines may be affected if you take Darunavir Sandoz.
Tell your doctor if you are taking:
- amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart disease) as the treatment effect or side effects of these medicines may be increased.
- apixaban, edoxaban, rivaroxaban, warfarin (to reduce blood clotting) as their treatment effect or side effects may change; Your doctor may need to check your blood.
- estrogen-based hormonal contraceptives or hormonal replacement therapy. Darunavir Sandoz may reduce their effect. If these are used as a method of contraception, alternative non-hormonal methods of contraception are recommended.
- ethinyl estradiol / drospirenone . Darunavir Sandoz may increase the risk of increased potassium levels caused by drospirenone.
- atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle damage may be increased. Your doctor will evaluate which cholesterol-lowering treatment best suits your specific situation.
- clarithromycin ( antibiotic )
- ciclosporin, everolimus, tacrolimus, sirolimus (to suppress the immune system) as the treatment effect or side effects of these medicines may be increased. Your doctor may want to do additional tests.
- Corticosteroids include betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammation of the eyes, joints, and muscles,s and other inflammatory conditions. If alternative medicines can not be used should these drugs be used only after medical evaluation and under close supervision by your doctor for side effects is of corticosteroid you
- buprenorphine / naloxone (opioid treatment drug)
- salmeterol (medicine to treat asthma )
- artemether/lumefantrine (a combination drug for malaria )
- dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)
- sildenafil, tadalafil, vardenafil (for erection problems or to treat a lung disease called pulmonary arterial hypertension ).
- telaprevir / pibrentasvir, simeprevir (for treating hepatitis C infection )
- fentanyl, oxycodone, tramadol (to treat pain).
The dosage of one of the other medicines may need to be changed as either their own or Darunavir Sandoz’s treatment effect or side effects may be affected if they are combined.
Tell your doctor if you are taking:
- alfentanil (powerful and short-acting painkiller for injection used in surgery)
- digoxin (to treat certain heart diseases)
- clarithromycin ( antibiotic )
- itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after a medical evaluation.
- rifabutin (against bacterial infections)
- sildenafil, vardenafil, tadalafil (for erection problems or high blood pressure in the blood vessels in the lungs)
- amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (for treating depression and anxiety)
- maraviroc (to treat HIV – infection )
- methadone (to treat opiate addiction)
- carbamazepine, clonazepam (to prevent seizures or to prevent certain types of nerve pain)
- colchicine (to treat gout or familial Mediterranean fever)
- bosentan (to treat high blood pressure in the blood vessels of the lungs)
- buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when taken as an injection, zolpidem (sedatives)
- perphenazine, risperidone, thioridazine (to treat psychiatric conditions).
This is not a complete list of medicines. Tell your doctor about all the medicines you are taking.
See section 3 “How to use Darunavir Sandoz”.
Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant, planning to become pregnant, or breast-feeding. Pregnant or breast-feeding mothers should not take Darunavir Sandoz with ritonavir unless specifically prescribed by a doctor.
Pregnant or breast-feeding mothers should not take Darunavir Sandoz with cobicistat.
HIV- infected women should not breast-feed their infants because there is both a risk of the baby becoming infected with HIV through breast milk and because you do not know how the medicine affects your baby.
Driving and using machines
Do not use machines or drive if you feel dizzy after taking Darunavir Sandoz.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
May cause allergic reactions.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Even if you feel better, do not stop taking Darunavir Sandoz and ritonavir without talking to your doctor.
Once treatment has been started, dose one or the dosage form must not be changed and treatment must not be stopped without instructions from a doctor.
Dosage for children from 3 years of age who weigh at least 15 kg and who have not taken antiretroviral drugs before (your child’s doctor decides this)
The doctor decides on an appropriate daily single dose based on the child’s body weight (see table below). This dose should not exceed the recommended dose for adults which is 800 m,g Darunavir Sando,z together with 100 mg ritonavir once daily.
Your doctor will tell you how many Darunavir Sandoz tablets and how much ritonavir (capsules, tablets, or solution) your child should take.
| Weight | One dose of Darunavir Sandoz is | One dose of ritonavir ais |
| 15–30 kg | 600 mg | 100 mg |
| 30–40 kg | 675 mg | 100 mg |
| over 40 kg | 800 mg | 100 mg |
a ritonavir oral solution: 80 mg per ml
Dosage for children from 3 years of age who weigh at least 15 kg and who have taken antiretroviral drugs before (your child’s doctor decides this)
The doctor decides on a dose based on the child’s body weight (see table below). The doctor decides whether the child should be dosed once or twice daily. This dose should not exceed the recommended dose for adults, which is 600 mg, Darunavir Sandoz, with 100 mg ritonavir twice daily or 800 mg Darunavir Sandoz with 100 mg ritonavir once daily.
Your doctor will tell you how many tablets Darunavir Sandoz and how much ritonavir (capsules, tablets, or solution) your child should take. There are tablets with other strengths available and your doctor may have prescribed a certain combination of tablets to achieve the right dosage.
Dosage twice-daily
| Weight | One dose is |
| 15–30 kg | 375 mg darunavir + 50 mg ritonavir twice daily |
| 30–40 kg | 450 mg darunavir + 60 mg ritonavir twice daily |
| over 40 kg * | 600 mg darunavir + 100 mg ritonavir twice daily |
* For children 12 years of age and older who weigh at least 40 kg, your child’s doctor will decide if Darunavir Sandoz 800 mg can be used once a day. This can not be given with this 75 mg or 600 mg tablets. Other strengths of darunavir are available.
Dosage once daily how
| Weight | One dose of Darunavir Sandoz is | One dose of ritonavir ais |
| 15–30 kg | 600 mg | 100 mg |
| 30–40 kg | 675 mg | 100 mg |
| over 40 kg | 800 mg | 100 mg |
a ritonavir oral solution: 80 mg per ml
Instructions for use for children
- The child should always take Darunavir Sandoz with ritonavir. Darunavir Sandoz cannot function properly without ritonavir.
- The child should take doses of Darunavir Sandoz and ritonavir twice daily or once daily. If Darunavir Sandoz has been prescribed twice a day, the child must take one dose in the morning and one dose in the evening. Your child’s doctor will determine the appropriate dosage for your child.
- The child should take Darunavir Sandoz with food. Darunavir Sandoz cannot function properly without food. The type of food is not important.
- The child should swallow the tablets with a drink such as water or milk.
- Darunavir Sandoz 75 mg has been developed for the treatment of children weighing less than 40 kg but may also be used in some other cases.
Dosage for adults who have not taken antiretroviral medicines before (your doctor will decide)
You will need another dose of Darunavir Sandoz that cannot be given with this 75 mg or 600 mg tablets. Other strengths of darunavir are available.
Dosage for adults who have taken antiretroviral medicines before (your doctor will decide)
Dose one is either:
- 1 tablet 600 mg Darunavir Sandoz together with 100 mg ritonavir twice daily.
- OR
- 1 tablet 800 mg Darunavir Sandoz together with 100 mg ritonavir once daily. Darunavir Sandoz 800 mg should only be used to achieve a dose of 800 mg once daily.
Discuss with your doctor which dosage is right for you.
Instructions for use for adults
- Always take Darunavir Sandoz with ritonavir. Darunavir Sandoz does not work properly without ritonavir.
- Take Darunavir Sandoz 600 mg in the morning with 100 mg ritonavir.
- Take 600 mg Darunavir Sandoz in the evening with 100 mg ritonavir.
- Take Darunavir Sandoz with food. Darunavir Sandoz does not work properly without food. The type of food is not important.
- Swallow the tablets with a drink, e.g. water or milk.
- 75 mg and 150 mg darunavir tablets have been developed for the treatment of children, but can also be used in adults in some cases.
How to open the child-resistant closure
The plastic jar has a child-resistant closure and must be opened as follows:
Press the plastic cap down while turning it counterclockwise.
Remove the cover.
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you notice this within 6 hours, you should take a dose immediately. Always take ritonavir with food. If you find it later than 6 hours after the missed dose, skip the missed dose one and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
Anti- HIV drugs can make you feel better. Even if you feel better, do not stop taking Darunavir Sandoz. Talk to your doctor first.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you experience any of the following side effects.
Liver problems that can sometimes be serious have been reported. Your doctor should take a blood sample before starting treatment with Darunavir Sandoz. If you have chronic hepatitis B or C infection, your doctor should take blood tests more often because you have an increased risk of developing liver problems. Talk to your doctor about signs and symptoms of liver problems. These may include yellowing of the skin or whites of the eyes, dark (tea-colored) urine, pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aches or pain,s and discomfort on the right side below the ribs.
Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash can also be a symptom of a rare difficult situation. It is therefore important that you talk to your doctor if you get a rash. Your doctor will advise you on how to deal with your symptoms or if Darunavir Sandoz needs to be stopped.
Other serious side effects were diabetes (common) and inflammation of the pancreas (less common).
A very common side effect is (can occur in more than 1 in 10)
- diarrhea.
Common side effects are (may affect up to 1 in 10)
- vomiting, nausea, stomach pain or tension, indigestion, flatulence
- headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in hands and feet, weakness, difficulty falling asleep
Less common side effects are (may affect up to 1 in 100)
- chest pain, ECG ( electrocardiogram ) changes, rapid heartbeat
- impaired or abnormal sensitivity of the skin, tingling, attention deficit, memory loss, balance problems
- difficulty breathing, cough, nosebleeds, irritation of the throat
- inflammation of the stomach or mouth, heartburn, sobbing, dry mouth, abdominal discomfort, constipation, belching
- kidney failure, kidney stones, difficulty urinating, frequent or heavy urination, sometimes at night
- hives, severe swelling of the skin or other tissues (usually lips or eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, the coloring of the nails
- muscle pain, muscle cramps or muscle weakness, pain in the extremities, osteoporosis
- impaired thyroid function. This can be seen in a blood test.
- high blood pressure, hemorrhage
- red or dry eyes
- fever, swelling of the legs due to fluid, malaise, irritability, pain
- a symptom of infection, herpes simplex
- erectile dysfunction, breast enlargement
- sleep problems, drowsiness, depression, anxiety, abnormal dreams, decreased sexual drive.
Rare side effects are (may affect up to 1 in 1000 users)
- a reaction called DRESS [severe rash that may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils ( white blood cell type ), the effect on liver, kidney, or lung]
- heart attack, or slow heartbeat, palpitations
- visual disturbance
- chills, feeling abnormal
- state of confusion or disorientation, altered mood, restlessness
- fainting, epileptic seizures, altered or lost sense of taste
- cold sores, vomiting, inflammation of the lips, dry lips, coating on the tongue
- Runny nose
- skin changes, dry skin
- stiffness in muscles or joints, joint pain with or without inflammation
- changes in certain blood levels. These can be seen in the results of blood and/or urine tests. Your doctor will explain this to you. Examples are: increase in certain white blood cells.
Some side effects are typical of anti- HIV medicines that belong to the same group as Darunavir Sandoz. These are:
- muscle aches, soreness, or weakness. In rare cases, muscle problems have been severe ( rhabdomyolysis ).
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister, and can after EXP. The expiration date is the last day of the specified month.
Opened can be used within 6 months, stored at a maximum of 25 ° C.
Blister: Do not store above 30 ° C.
Tablet jar: No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is darunavir.
Each film-coated tablet contains 75 mg or 600 mg darunavir.
Other ingredients are
- Tablet core: cellulose, microcrystalline (E460); silica, colloidal , anhydrous (E551); crospovidone (type A) (E1202); magnesium stearate (E470b).
- Tablet coating: polyvinyl alcohol (E1203); macrogol (3350) (E1521); titanium dioxide (E171); talc (E553b). Darunavir Sandoz 600 mg film-coated tablets also contain: para-orange (E110).
What the medicine looks like and the contents of the pack
Darunavir Sandoz 75 mg film-coated tablets:
White, capsule-shaped film-coated tablet, debossed with “75” on one side and smooth on the other. Dimensions: approx. 8.6 mm x 4.6 mm.
Darunavir Sandoz 600 mg film-coated tablets:
Orange, oval, film-coated tablet, debossed with “600” on one side and smooth on the other. Dimensions: approx. 20.1 mm x 10.1 mm.
Darunavir Sandoz 75 mg and 600 mg film-coated tablets are supplied in Aluminum-PVC / PE / PVDC perforated blisters or HDPE cans with polypropylene (PP) child-resistant closure.
Pack sizes:
Darunavir Sandoz 75 mg film-coated tablets:
Tablet jars: 480 film-coated tablets.
Perforated blister packs: 10, 30, 60, 90, 120 film-coated tablets.
Darunavir Sandoz 600 mg film-coated tablets:
Tablet cans: 60, 120 (2×60), 180 (3×60), 240 (4×60) film-coated tablets.
Perforated blister packs: 10, 30, 60, 90, 120 film-coated tablets.
Perforated single-dose blister packs: 60×1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Verovškova ulica 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Saxony-Anhalt, 39179 Barleben, Germany
or
Remedica Ltd, Aharon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus